UROFLOW 2 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
2. What is Uroflow and what is it used for
3. Important information before using Uroflow
   1. When not to use Uroflow:
   2. Warnings and precautions
   3. Uroflow and other medicines
   4. Uroflow with food and drink
   5. Pregnancy and breastfeeding
   6. Driving and operating machinery
   7. Uroflow contains sodium
4. How to use Uroflow
   1. Use in children and adolescents
   2. Using a higher dose of Uroflow than recommended
   3. Missing a dose of Uroflow
   4. Stopping Uroflow treatment
5. Possible side effects
   1. You should immediately stop using the medicine and contact your doctor if you experience any of the following side effects with unknown frequency:
   2. Reporting side effects
6. How to store Uroflow
7. Contents of the packaging and other information
   1. What Uroflow contains
   2. What Uroflow looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. For more information about the medicine and its names in the Member States of the European Economic Area, please contact:

Leaflet attached to the packaging: information for the user

UROFLOW 1, 1 mg, coated tablets
UROFLOW 2, 2 mg, coated tablets
Tolterodine tartrate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Uroflow and what is it used for
• 2. Important information before using Uroflow
• 3. How to use Uroflow
• 4. Possible side effects
• 5. How to store Uroflow
• 6. Contents of the packaging and other information

1. What is Uroflow and what is it used for

Uroflow belongs to a group of medicines that reduce bladder muscle tension.
Uroflow is used to treat symptoms of an overactive bladder, such as: sudden, frequent urination or incontinence with urgent urination.
The medicine is intended for use in adults.

2. Important information before using Uroflow

When not to use Uroflow:

• if the patient is allergic to tolterodine or any of the other ingredients of this medicine (listed in section 6),
• if the patient has reduced ability to empty the bladder,
• if the patient has glaucoma (high pressure in the eyeball and eye pain) that is difficult to treat,
• if the patient has myasthenia (nerve-muscle function disorders with muscle weakness),
• if the patient has severe ulcerative colitis (inflammation of the intestine with ulcers and bloody diarrhea) or toxic megacolon (a life-threatening complication of ulcerative colitis or other intestinal diseases).

Warnings and precautions

Before starting to take Uroflow, you should discuss it with your doctor or pharmacist:

• if the patient has difficulty urinating or a weak urine stream,
• if the patient has acute abdominal distension with an impact on digestion and movement of food or has had or has severe constipation,
• if the patient has kidney or liver problems. In such cases, the doctor will usually reduce the recommended dose of the medicine,
• if the patient has autonomic neuropathy (a nerve disorder, sometimes with diabetes, which can lead to diarrhea, erection disorders, or low blood pressure),
• if the patient has a hiatal hernia (displacement of a fragment of the stomach from the abdominal cavity to the thoracic cavity through a natural opening in the diaphragm),
• if the patient has heart rhythm disorders, such as:
• abnormal ECG recording,
• slow heart rate (bradycardia) or if the patient is taking any medicines that are known to affect heart rate,
• significant pre-existing heart diseases, such as:
• cardiomyopathy (heart muscle weakness);
• myocardial ischemia (reduced blood flow to the heart);
• heart rhythm disorders (irregular heart rhythm);
• heart failure.
• if the patient has low potassium (hypokalemia), calcium (hypocalcemia), or magnesium (hypomagnesemia) levels in the blood.

Uroflow and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Some medicines may interact with Uroflow and enhance its effect:

• antibiotics containing erythromycin and clarithromycin,
• medicines used to treat fungal infections,
• medicines used to treat HIV infections,
• medicines used to treat irregular heart rhythm (containing, for example, amiodarone, sotalol, quinidine, procainamide),
• other medicines with a similar effect to Uroflow (antimuscarinic properties) or medicines with an opposite effect to Uroflow (cholinergic properties).

Uroflow may reduce the effect of medicines that stimulate gastrointestinal motility (medicines containing metoclopramide or cisapride). If you are unsure whether the above information applies to you, you should consult your doctor.

Uroflow with food and drink

The medicine can be taken independently of meals, with a glass of water.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Uroflow is not recommended during pregnancy.
Breastfeeding women should avoid using this medicine.

Driving and operating machinery

Uroflow may cause blurred vision and reduce reaction ability. You should always consult your doctor if you plan to drive or operate machinery.

Uroflow contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to use Uroflow

This medicine should always be used as directed by your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist.
Adults (including elderly patients)
The recommended dose is 2 mg (1 Uroflow 2 tablet) twice a day. The tablet should be swallowed whole.
Patient with kidney or liver impairment
The recommended dose is 1 mg (1 Uroflow 1 tablet) twice a day.
After 2 or 3 months, the effectiveness of the treatment should be re-evaluated.

Use in children and adolescents

Uroflow is not recommended for use in children and adolescents.

Using a higher dose of Uroflow than recommended

You should not take more tablets than your doctor has prescribed. If you accidentally take more tablets than recommended, you should immediately seek medical attention or go to the nearest hospital. If a child accidentally takes the medicine, you should immediately contact a doctor.

Missing a dose of Uroflow

If you forget to take a tablet at the usual time, you should take it as soon as you remember, unless it is time for the next dose of the medicine.
You should not take a double dose to make up for a missed dose.

Stopping Uroflow treatment

You should not stop treatment.
Your doctor will inform you about the duration of treatment with Uroflow.
If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Uroflow can cause side effects, although not everybody gets them.

You should immediately stop using the medicine and contact your doctor if you experience any of the following side effects with unknown frequency:

if you experienceany of the following side effects with unknown frequency:

• allergic reaction with skin rash, facial swelling, or difficulty breathing (angioedema);
• hives, sudden swelling in the eye area, feeling of pressure on the chest with difficulty breathing or swallowing, blue skin color, low blood pressure (anaphylactoid reaction).

During treatment with tolterodine (the active substance of Uroflow), the following side effects may occur (divided according to their frequency); if any of these side effects bother you, you should contact your doctor, who may reduce the dose of the medicine.
Very common(may occur more often than in 1 in 10 patients):

• dry mouth,
• headache.

Common(may occur in up to 1 in 10 patients):

• bronchitis,
• dizziness of central origin, drowsiness, sensory disturbances - feeling of tingling in fingers and toes (paresthesia),
• dry eyes, abnormal vision (blurred vision),
• dizziness of peripheral origin (vestibular),
• palpitations,
• discomfort in the stomach after meals (indigestion), constipation, abdominal pain, bloating, vomiting, diarrhea,
• painful or difficult urination, urinary retention,
• dry skin,
• fatigue, chest pain, water retention in the body causing swelling (e.g., ankles),
• weight gain.

Uncommon(may occur in up to 1 in 100 patients):

• allergic reactions (allergic),
• nervousness,
• rapid heart rate, heart failure, irregular heart rhythm,
• heartburn,
• memory disorders.

Unknown(frequency cannot be estimated from available data):

• confusion, hallucinations, and disorientation,
• redness of the skin,
• in patients treated for dementia, cases of worsening of dementia symptoms have also been reported.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
Al. Jerozolimskie 181 C

• 02 - 222 Warsaw Tel.: + 48 22 49 21 301 Fax: + 48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl By reporting side effects, you can help gather more information on the safety of the medicine. Side effects can also be reported to the marketing authorization holder or its representative in Poland.

5. How to store Uroflow

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP".
The expiry date refers to the last day of the month.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Uroflow contains

The active substance is tolterodine tartrate. Each coated tablet contains 1 mg or 2 mg of tolterodine tartrate.
The medicine also contains:
Tablet core:microcrystalline cellulose, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, sodium stearyl fumarate.
Tablet coating:
Uroflow 1: hypromellose 2910/5, macrogol 6000, titanium dioxide (E171), yellow iron oxide (E172), talc.
Uroflow 2: hypromellose 2910/5, macrogol 6000, titanium dioxide (E171), talc.

What Uroflow looks like and contents of the pack

Uroflow 1: yellow, round, biconvex coated tablets.
Uroflow 2: white, round, biconvex coated tablets.
Pack size: 28 or 56 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s., U kabelovny 130, Dolni Měcholupy, 10237 Praha 10, Czech Republic

Manufacturer

Zentiva, k.s., U kabelovny 130, Dolni Měcholupy, 10237 Praha 10, Czech Republic

For more information about the medicine and its names in the Member States of the European Economic Area, please contact:

Zentiva Polska Sp. z o.o.
Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00
Date of last revision of the leaflet:January 2021